FDA Biostatistics: Biomarker Development & Validation Fellowship
*Applications will be reviewed on a rolling-basis.
Multiple research opportunities are currently available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences/Office of Biostatistics (OB) located in Silver Spring, Maryland.
In investigational medical imaging drug development, conventional performance characteristics have been the norm as the primary efficacy endpoints. Depending on the indications, a modeling approach may be proposed and employed. In contrast, a modeling approach is often employed to show clinical utility of a biomarker. We propose comparing the two modeling approaches using data examples and simulation studies. The research findings shall shed lights on clinical meaningfulness of each approach to inform future statistical recommendations.
Under the guidance of the mentor, the participant will gain understanding related to design and conduct of extensive simulation studies, will identify and evaluate statistical approaches/methods for biomarker or imaging and be able to identify examples to illustrate utilities of methodologies where feasible. The participant will also be given the opportunity to prepare a manuscript to include results and conclusions.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for three months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment can be full-time or part-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.